Senior Manager, Quality Control
Greater Madison, WI Area
Quality /
Full-Time /
On-site
COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
eGenesis is seeking an experienced and proactive Senior Manager, Quality Control to lead the design, implementation, and continuous improvement of the Environmental Monitoring (EM) and Microbiology programs across our GMP manufacturing facilities in Rensselaer (REN) and Middleton (MID). This role will have dual responsibilities: overseeing routine EM operations and leading the operational readiness of the new QC Microbiology lab at the MID site, including strategy and execution for water sampling, microbial ID capabilities, and critical QC systems. This individual will manage a growing team and collaborate cross-functionally with Manufacturing, Facilities, and QA. The position reports to the Senior Director, Head of Quality.
PRIMARY RESPONSIBILITIES
- Oversee environmental monitoring programs (viable/non-viable air, surface, personnel, water) at REN and MID to ensure compliance with cGMP and regulatory standards (FDA, EU Annex 1).
- Lead daily EM operations, data review/trending, excursion management, and CAPA implementation.
- Drive cross-functional contamination control initiatives and risk mitigation strategies.
- Act as the primary SME during audits and inspections for EM, contamination control, and microbial trending.
- Lead the buildout and qualification of the new QC Microbiology lab at the Middleton (MID) site to support in-house EM testing and microbial identification capabilities.
- Oversee qualification of QC instruments (e.g., incubators, particle counters, ID systems like MALDI-TOF, qPCR), utilities, and workflows supporting microbiology testing.
- Establish and validate a site-wide water sampling and testing strategy, aligned with regulatory standards and phase-appropriate GMP compliance.
- Author and/or review protocols and reports related to lab qualification, method validation, and readiness assessments.
- Directly supervise and mentor QC team members responsible for EM sampling, lab operations, and method execution.
- Collaborate with QA, Manufacturing, Validation, and Facilities teams to align EM practices and lab readiness with site and program needs.
- Participate in facility and equipment readiness reviews, CCRB, and project planning meetings to ensure Quality alignment.
- Support harmonization of QC systems, SOPs, and training across sites for a unified Quality culture.
- Develop and maintain SOPs, forms, protocols, and work instructions related to EM and QC Microbiology functions.
- Ensure timely and accurate documentation in LIMS, QMS (e.g., Veeva, Qualio), and related quality systems.
- Lead or support deviation investigations and change controls related to environmental excursions, water testing, or lab performance.
- This position will require some travel (~20% of time) between manufacturing site but primary location will be Middleton, WI.
BASIC QUALIFICATIONS
- BS/MS in microbiology, biology or a related scientific discipline with 3-5 years industry experience in a QC laboratory.
- Proficient in microbiology methods (plate enumeration, growth promotion, microbial ID, etc.) and aseptic technique needed to perform EM in a GMP environment.
- Familiarity with regulatory guidance (FDA, EU Annex 1, USP <61>, <62>, <85>, <1116>, etc.) and industry best practices.
- Excellent leadership, communication, and problem-solving skills.
- Experience with digital monitoring tools (e.g., ELLAB, MODA, LIMS) and quality systems such as Veeva is a plus.
- The ability to work and lead in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is essential.
- Effective communication skills, both verbal and written, at all levels and across various functions.
